re: usa 3/12 dead. vcr 3/7dead. You are correct Thurlow, the trials are at different stages so it is difficult to compare. Also, we do not know trial selection criteria (how ill the patients are).
Furthermore, phase I trials are rarely big enough to give statistically significant data on efficacy (7 and 12 patients is nowhere near a big enough sample). They are used to assess safety.
So, what seems clear is that, with both trials claiming no device-related deaths, they will both proceed to larger phase II studies.
VCR
ventracor limited
the product is already licenced in the usa., page-12
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